It is estimated that over two million women have had breast implants since their introduction in the mid-60's. Specifically, in 1990, over 132,000 women in the U.S. alone underwent this surgical procedure. Reconstructive surgery following mastectomy or trauma accounts for many of the implant operations, while the remainder of the implant operations were performed to enlarge or reshape the breasts.
Three common types of breast implant devices have been marketed in the U.S.:
Silicone envelope filled with silicone gel. This is the most frequently implanted product. PA1 Silicone envelope filled with saline. PA1 A double lumen implant consisting of an inner silicone envelope filled with silicone gel and an outer envelope that is filled with saline.
The surface of the devices may be either smooth or textured. The textured surface is a silicone or a polyurethane foam coating which is no longer marketed in the U.S. since it was found to degrade and release a known carcinogen in animals.
In 1988, based on increasing safety concerns, the FDA informed manufacturers of the agency's intention to request PMA submission for these products. A Jul. 9, 1991 deadline was set for the manufacturers of silicone gel-filled breast implants to submit data. The manufacturers of saline-filled implants were also advised that they would be required to submit data at a later date. Assisted by the advice of an outside advisory panel, on Jan. 6, 1992, the agency placed a moratorium on the distribution of silicone filled implants.
The moratorium was based on reports implicating the implants with problems such as bleeding, infection, capsular contracture, calcium deposition, rupture, local neurosensory changes, interference with mammography, autoimmune or connection tissue diseases and risk of cancer.
Thus, it would be a significant contribution to the medical device art to provide a cosmetic or prosthetic implant device that does not utilize a silicone gel.
It is an object of the present invention to provide a new medical device comprising an envelope filled with a bioabsorbable liquid.